23 Nov Surveillance Data Released for Treatment of Idiopathic Pulmonary Fibrosis with OFEV-Nintedanib
Imre Noth, M.D.
MedicalResearch.com Interview with:
Imre Noth, M.D.
Professor of Medicine and Director of the Interstitial Lung Disease Programme
The University of Chicago
Medical Research: What is the background for this study? What are the main findings?
Dr. Noth: In 2014, OFEV® (nintedanib) became one of the first FDA-approved drug treatments for idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease that causes permanent scarring of the lungs. In this post-marketing surveillance study in the United States, treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA.
Post-marketing surveillance of the safety and tolerability of OFEV in the United States has been collected in the Boehringer Ingelheim drug safety and reporting database since OFEV was first approved on October 15, 2014. Until May 31, 2015, 3,838 people were treated with OFEV for a length of time ranging from 14 to 265 days (on average 88 days). The most frequently reported side effects were gastrointestinal in nature and included diarrhea, nausea, vomiting and decreased appetite. Diarrhea was the most frequently reported individual side effect, occurring at a similar frequency to that observed in the clinical trials supporting approval. No new safety concerns were identified.
Medical Research: What should clinicians and patients take away from your report?
Dr. Noth: These first results from the post-marketing surveillance study, which showed a consistent safety profile of OFEV as described in the prescribing information, are important because they provide healthcare providers with additional information when considering OFEV for their patients with IPF. Due to its rarity, there is very little public awareness of idiopathic pulmonary fibrosis, and a lack of understanding by many in the healthcare community about how to best recognize and treat the disease.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Noth: The approval of OFEV was supported by evidence from three well-designed studies part of a comprehensive clinical trial program, and it is key to continually analyze the real-world experiences of people on therapy given the limited data on IPF. Early diagnosis and proper care are critical to helping people treat their condition.
Citation:
Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF): data from post-marketing surveillance in the United States
Abstract presented at the: Pulmonary Fibrosis Foundation’s PFF Summit 2015 in Washington, D.C.
Imre Noth, M.D (2015). Surveillance Data Released for Treatment of Idiopathic Pulmonary Fibrosis with OFEV-Nintedanib
Last Updated on November 23, 2015 by Marie Benz MD FAAD